RecruitingPhase 1

Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

Russia45 participantsStarted 2026-01-26

Plain-language summary

This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Voluntary, personally signed ICF obtained prior to any study procedures; * Males and females aged 18 to 45 years (inclusive) of Caucasian race; * Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol; * Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive); * Heart rate (HR) from 60 to 89 beats/min (inclusive); * Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive); * Body temperature from 36.0°C to 36.9°C (inclusive); * Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with body weight ≥ 55 kg for males and ≥ 45 kg for females; * Commitment to adhere to highly effective contraceptive methods during the study participation period and for 30 days thereafter; documentation of negative urine pregnancy test for women of childbearing potential. Noninclusion Criteria: * History of clinically significant allergic reactions; * Hypersensitivity to hymecromone and trimebutine and/or excipients included in the study drug in anamnesis; * Drug intolerance to hymecromone and trimebutine and/or excipients included in the study drug in the anamnesis; * Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption in the anamnesis; * Chronic diseases of the kidney, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, resp…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics - Cmax

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - tmax

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC0-t

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC0-inf

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC ratio

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - t1/2

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - kel

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Trial details

NCT IDNCT07594977

SponsorValenta Pharm JSC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Chronic Cholecystitis trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pharmacokinetics - Cmax

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - tmax

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC0-t

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC0-inf

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - AUC ratio

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - t1/2

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)

Pharmacokinetics - kel

Timeframe: From 0 to 48 hours (days 1-3 and 8-10)